Cleared Traditional

K252250 - Vista 300/Vista 300 S (FDA 510(k) Clearance)

Also includes:
Vista 300 Non-Inv Model A, US (2601064) Vista 300 Invasive Model C, US (2601065) Vista 300 S Non-Inv Model A, US (2602425) Vista 300 S Invasive Model B, US (2602426) Vista 300 S Invasive Model C, US (2602427)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K252250 · Shanghai Draeger Medical Instrument Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2026
Decision
267d
Days
Class 2
Risk

K252250 is an FDA 510(k) clearance for the Vista 300/Vista 300 S. Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Shanghai Draeger Medical Instrument Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on April 10, 2026 after a review of 267 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Shanghai Draeger Medical Instrument Co., Ltd. devices

Submission Details

510(k) Number K252250 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2025
Decision Date April 10, 2026
Days to Decision 267 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
142d slower than avg
Panel avg: 125d · This submission: 267d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

All 421
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K252250.
Vista CMS
K250349 · Shanghai Draeger Medical Instrument Co., Ltd. · Apr 2026
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K253170 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Apr 2026
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K252726 · Philips Medizin Systeme Boeblingen GmbH · Feb 2026
Corvair Monza
K252589 · AliveCor, Inc. · Jan 2026
Multi-parameter Patient Monitor (N10)
K250854 · Shenzhen Comen Medical Instruments Co.,Ltd · Dec 2025
IntelliVue Patient Monitor MX750
K251702 · Philips Medizin Systeme B?blingen GmbH · Nov 2025